The present invention relates to bioactive Factor produced, isolated, and separated from either an aloe vera leaf or a product derived or processed from an aloe leaf, their preparations, and their uses. More specifically, the present invention relates to bioactive Factors produced, isolated and separated from an aloe vera leaf, aloe gel fillet, aloe raw gel, freeze-dried aloe vera gel extract, bulk acetylated mannan or bulk pharmaceutical mannan utilizing different sizing processes, their processes or preparations, and their uses.
Aloe is a tropical or subtropical plant characterized by lance-shaped leaves with jagged edges and sharp points. For centuries, this plant has been considered to have, and has been used for its, medicinal and therapeutic properties without any clear understanding or scientific analysis of the bases for such properties. Further, it is known that the biological activities of fresh aloe plant decay very rapidly.
Because of this lack of knowledge about the aloe plant and its characteristics, most methods employed for the processing of the plant result in end products which do not consistently achieve desired results. Further, aloe leaves contain anthraquinones in its yellow sap. The anthraquinone-containing yellow sap is known to have a laxative effect with a reputation as an extremely irritating cathartic. Traditional processes for the production of various aloe products typically involved crushing (pressure rollers), grinding (e.g., use of Thompson aloe leaf slitter), or pressing (TCX pressure extruder) of the entire leaf of the aloe plant to produce an aloe vera juice, followed by various steps of filtration and stabilization of the juice. The resulting mixture is then incorporated in, or mixed with, other solutions or agents to produce the products which could be, for example, a cosmetic, a health food drink, or a topical ointment. Unfortunately, because of improper processing procedures, many of these so-called aloe products contain no bioactive chemical substances or ingredients.
The principal disadvantage of such state of the art processes is the failure to recognize, and to take into account, that different fractions or components of the aloe leaf have different kinds of biological activities. These different fractions have characteristics that may not only be inconsistent with the intended use of the final product, but in many instances were deleterious to such use. Further, unless carefully controlled processes are used in processing the leaves of the aloe plant, the active chemical substances, or ingredients, of the leaves are destroyed during the process.
Aloe vera leaves contain a variety of chemical substances and components. Mixtures of active chemical substances of aloe leaves have been identified, isolated and stabilized as described in U.S. Pat. Nos. 4,735,935, 4,851,224, 4,917,890, 4,957,907, 4,959,214, and 4,966,892, each of these is incorporated herein by reference. One group of the active chemical substances has been referred to as aloe vera mucilaginous polysaccharides. Even the aloe vera mucilaginous polysaccharides are made up of a mixture of polysaccharides. The term "polysaccharides" has been used loosely to include both oligomers and polymers of carbohydrates. A group of such polysaccharides has been given the name acemannan. Acemannan is an ordered linear polymer of substantially acetylated mannose monomers.
The biological, or physiological, activities of aloe vera mucilaginous polysaccharides and their pharmaceutical applications have been the object of numerous research studies at a number of laboratories, including Carrington Laboratories. Uses of aloe products have been described in U.S. Pat. Nos. 5,106,616, 5,118,673, 5,308,838, 5,441,943, and 5,443,830, each assigned to Carrington Laboratories, Inc., the content of each of which is incorporated by reference herein. These studies have primarily focused on the activities of bioactive chemical substances of aloe vera as antiviral agents, antitumor agents, immunostimulants, immunomodulators, vaccine adjuvants, means of reducing opportunistic infections, means of controlling inflammation, and means of stimulating the wound healing processes.
Aloe vera mucilaginous polysaccharides have been shown in controlled studies to increase the rate of healing in animals. Aloe vera mucilaginous polysaccharides have also been shown to be an effective treatment for gastric ulcers in animal studies.
Acemannan, for example, has been shown in laboratory studies to increase up to 300% in 48 hours the replication of fibroblasts in tissue culture which are known to be responsible for healing burns, ulcers and other wounds of the skin and of the gastrointestinal lining.
Over a three year period, laboratory rats, the stomachs of which react similarly to that of humans, were tested. Acemannan was found to be equivalent to or superior to current medications used for the treatment of gastric ulcers. Most such products act to inhibit hydrochloric acid in the stomach. Acemannan works on a different principle and does not alter the natural flow of digestive acids.
In view of the known wide spectrum of biological activities possessed by leaves of aloe plant, and in view of the known complex mixtures of biologically active components and substances found in the leaves of aloe plant, it is desirable to isolate and separate different biologically active Factor from the leaves of the aloe plant. A need has arisen for sizing different Factors of bioactive chemical substances of aloe vera leaves.